U.S. patent application number 14/652243 was filed with the patent office on 2015-12-24 for vein access needle guide assembly and methods of use.
This patent application is currently assigned to V-Align, Inc.. The applicant listed for this patent is V-ALIGN, INC.. Invention is credited to Harry Allan Alward, Guy Osborne, Sundaram Ravikumar, Vikram Ravikumar.
Application Number | 20150367085 14/652243 |
Document ID | / |
Family ID | 54868710 |
Filed Date | 2015-12-24 |
United States Patent
Application |
20150367085 |
Kind Code |
A1 |
Ravikumar; Sundaram ; et
al. |
December 24, 2015 |
VEIN ACCESS NEEDLE GUIDE ASSEMBLY AND METHODS OF USE
Abstract
A needle guide assembly for vein access including (a) a guide
having a peripheral edge, a convex portion, a concave portion and
an aperture, where the concave portion and the convex portion meet
each other to define the aperture between the concave portion and
the convex portion, each of the convex portion and the concave
portion extending away from the aperture in opposite directions
from each other in a tapering manner and terminating the tapering
at respective locations away from the peripheral edge, the convex
portion being made of a transparent or translucent material, and
(b) a retaining means for retaining the guide to skin. A
venipuncture method includes retaining the needle guide assembly
onto the skin of a patient and using the needle guide assembly to
guide a needle to puncture the skin and access a vein.
Inventors: |
Ravikumar; Sundaram;
(Briarcliff Manor, NY) ; Osborne; Guy; (Trumbull,
CT) ; Alward; Harry Allan; (Shelton, CT) ;
Ravikumar; Vikram; (Briarcliff Manor, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
V-ALIGN, INC. |
Dobbs Ferry |
NY |
US |
|
|
Assignee: |
V-Align, Inc.
Dobbs Ferry
NY
|
Family ID: |
54868710 |
Appl. No.: |
14/652243 |
Filed: |
October 7, 2014 |
PCT Filed: |
October 7, 2014 |
PCT NO: |
PCT/US2014/059576 |
371 Date: |
June 15, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61648585 |
May 17, 2012 |
|
|
|
61887839 |
Oct 7, 2013 |
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Current U.S.
Class: |
604/510 ;
604/116 |
Current CPC
Class: |
A61M 2025/0273 20130101;
A61M 25/02 20130101; A61M 2005/1586 20130101; A61M 5/427 20130101;
A61M 5/3287 20130101 |
International
Class: |
A61M 5/42 20060101
A61M005/42; A61M 25/02 20060101 A61M025/02 |
Claims
1. A needle guide assembly for vein access, comprising a guide
having a peripheral edge, a convex portion, a concave portion and
an aperture, the concave portion and the convex portion meeting
each other to define the aperture between the concave portion and
the convex portion, each of the convex portion and the concave
portion extending away from the aperture in opposite directions
from each other in a tapering manner and terminating the tapering
at respective locations away from the peripheral edge, the convex
portion being made of a transparent or translucent material; and
retaining means for retaining the guide to skin.
2. The assembly of claim 1, further characterized by a kit that
contains a sterile package enclosing the guide, the means for
retaining the guide to skin, a packaged sterile alcohol swab, a
packaged sterile needle and a packaged sterile bandage.
3. The assembly of claim 1 or 2, characterized in that the convex
portion extends from a topside of the guide, the concave portion
extends from an underside of the guide.
4. The assembly of claim 1 or 2, characterized in that the
retaining means includes an adhesive layer having an opening in
alignment with at least one of the concave and convex portions.
5. The assembly of claim 4, characterized in that the concave
portion fits into the opening in the adhesive layer.
6. The assembly of claim 1 or 2, characterized in that the guide
has two sets of pairs of opposite edges that form the periphery,
the convex portion and the concave portion each being symmetric
relative to a line of symmetry, further comprising two side straps
adhered to the guide and extending outward past one of the sets of
pairs of the opposite edges, each of the two side straps having a
respective edge spaced away from each other that are substantially
equidistant from the line of symmetry.
7. The assembly of claim 1 or 2, characterized in that the guide
has two sets of pairs of opposite edges that form the periphery,
the opposite edges of one of pairs of the two sets each defining a
respective notch so as to provide for two notches, the concave
portion and the convex portion extending from the aperture away
from each other between the two notches so that the convex portion
tapers in a direction toward one of the two notches and the concave
portion tapers in a direction toward a remaining one of the two
notches.
8. The assembly of claim 1 or 2, characterized in that the guide
has a two sets of pairs of opposite edges that form the periphery,
at least one of the opposite edges of one of the pairs of the two
sets defining a notch, at least one of the convex portion and the
concave portion tapering in a direction toward the notch.
9. The assembly of claim 8, characterized by said retaining means
including an adhesive layer that has a further notch in alignment
with the notch of the guide and being substantially identical in
shape to that of the notch of the guide.
10. The assembly of claim 1 or 2, characterized in that the guide
has a direction indicator marked on a topside of the guide that
points in a same direction that the convex portion tapers.
11. The assembly of claim 1, characterized by a needle stabilizer
having a channel that extends in a channel direction to accommodate
insertion of a needle, spacing the needle stabilizer from the guide
by a distance sufficient to enable simultaneous insertion of the
needle through both the channel of the needle stabilizer and the
aperture of the guide in alignment so that a tip of needle enters
the convex portion of the guide as a portion of a remainder of the
needle is within the channel.
12. The assembly of claim 1 or 2, characterized in that the
retaining means includes an adhesive layer, the adhesive layer
having an opening accommodating insertion of the concave portion
within the opening and defining a space in alignment with the
convex portion.
13. The assembly of claim 1 or 2, characterized in that the
retaining means includes an adhesive layer, that adhesive layer
having an adhering side, further characterized by a paper layer
against the adhering side of the adhesive layer and peelable under
manual force for removal from the adhering side.
14. The assembly of claim 1 or 2, characterized in that the convex
portion extends from a topside of the guide, the topside of the
guide having a depression forming the concave portion.
15. A method of assembling a needle guide assembly for vein access,
comprising providing a guide having a peripheral edge, a convex
portion, a concave portion and an aperture, the concave portion and
the convex portion meeting each other to define the aperture
between the concave portion and the convex portion, each of the
convex portion and the concave portion extending away from the
aperture in opposite directions from each other in a tapering
manner and terminating the tapering at respective locations away
from the peripheral edge, the convex portion being made of a
transparent or translucent material; and retaining the guide to
skin.
16. The method of claim 15, further characterized by the steps of:
(a) locating a vein on a skin surface for insertion of a needle;
(b) cleansing an area of the skin surface in relation to the vein
chosen for insertion of the needle; (c) palpating the vein; (d)
adhering the guide onto the skin in relation to the chosen vein to
effect the retaining of the guide to the skin; (e) inserting a
distal needle tip of the needle along the concave portion of the
guide through the aperture and to reach the skin surface; and (f)
securing the needle under the convex portion of the guide.
17. The method of claim 16, further characterized by the steps of:
(g) attaching a collection container to a proximal end of the
needle to receive drawn blood from the vein; (h) removing the
distal needle tip away from the skin surface; (i) removing the
guide from the skin surface; (j) placing a sterile piece of gauze
with pressure on the skin surface where the distal needle tip was
removed; and (k) placing a sterile bandage on the skin surface
where the distal needle tip was removed.
18. The method claim 16, further characterized by the steps of: (g)
attaching a proximal portion of the needle to a container
containing medicine; (h) discharging the medicine through the
needle to pass through the distal needle tip; (i) removing the
distal needle tip from the skin surface; (j) removing the guide
from the skin surface; (k) placing a sterile piece of gauze with
pressure on the skin surface where the distal needle tip was
removed; and (l) placing a sterile bandage on the skin surface
where the distal needle tip was removed.
19. The method of claim 15, characterized by extending the convex
portion from a topside of the guide, and extending the concave
portion from an underside of the guide.
20. The method of claim 15, characterized in that the retaining
includes retaining with an adhesive layer having an opening in
alignment with at least one of the concave and convex portions.
21. The method of claim 15, characterized by fitting the concave
portion into the opening in the adhesive layer.
22. The method of claim 15, characterized in that the guide two
sets of pairs of opposite edges that form the periphery, the convex
portion and the concave portion each being symmetric relative to a
line of symmetry, further comprising adhering two side straps to
the guide and extending the two side straps outward past one of the
sets of pairs of the opposite edges, each of the two side straps
having a respective edge spaced away from each other that are
substantially equidistant from the line of symmetry.
23. The method of claim 15, characterized in that the guide has a
two sets of pairs of opposite edges that form the periphery, the
opposite edges of one of pairs of the two sets each defining a
respective notch so as to provide for two notches, the concave
portion and the convex portion extending from the aperture away
from each other between the two notches so that the convex portion
tapers in a direction toward one of the two notches and the concave
portion tapers in a direction toward a remaining one of the two
notches.
24. The method of claim 15, characterized in that the guide has two
sets of pairs of opposite edges that form the periphery, at least
one of the opposite edges of one of the pairs of the two sets
defining a notch, at least one of the convex portion and the
concave portion tapering in a direction toward the notch.
25. The method of claim 15, characterized by said retaining
including retaining with an adhesive layer that has a further notch
in alignment with the notch of the guide and being substantially
identical in shape to that of the notch of the guide.
26. The method of claim 15, characterized in that the guide has a
direction indicator marked on a topside of the guide that points in
a same direction that the convex portion tapers.
27. The method of claim 15, characterized by a needle stabilizer
having a channel that extends in a channel direction to accommodate
insertion of a needle, spacing the needle stabilizer from the guide
by a distance sufficient to enable simultaneous insertion of the
needle through both the channel of the needle stabilizer and the
aperture of the guide in alignment so that a tip of needle enters
the convex portion of the guide as a portion of a remainder of the
needle s within the channel.
28. The method of claim 15, characterized in that the retaining
includes retaining with an adhesive layer, the adhesive layer
having an opening accommodating insertion of the concave portion
within the opening and defining a space in alignment with the
convex portion.
29. The method of claim 15, characterized in that the retaining
includes retaining with an adhesive layer, that adhesive layer
having an adhering side, further characterized by a paper layer
against the adhering side of the adhesive layer and peelable under
manual force for removal from the adhering side.
30. The method of claim 15, characterized by extending the convex
portion from a topside of the guide, the topside of the guide
having a depression forming the concave portion.
Description
RELATED APPLICATIONS
[0001] This application claims priority from provisional
application Ser. No. 61/648,585 filed Oct. 7, 2013 and PCT
Application No. PCT/US14/059576 filed on Oct. 7, 2014.
FIELD OF THE INVENTION
[0002] The present invention relates to medical products and
methods of their use, and more particularly to a needle guide
assembly and method of venipuncture, through which needles can be
easily and accurately placed into a patient's vein.
BACKGROUND OF THE INVENTION
[0003] Intravenous access is a ubiquitous component of some of the
most common medical treatments and procedures. Most common access
is a percutaneous injection via piercing the skin with a hollow
needle inserted into a vein, whether the vein is in the person's
hand, arm, groin, neck or other body part. Venipuncture to obtain a
blood sample is most commonly obtained from the median cubital
vein, which lies within the cubital fossa anterior to the elbow, as
this vein lies close to the surface of the skin so it is easily
accessible while not surrounded by many nerves so as to minimize
the pain for the individual.
[0004] Phlebotomy via venipuncture occurs hundreds of millions of
time per year worldwide, if not a billion. Accessing a vein is
critical, because veins are the conduit through which medical
professionals draw blood from as well as inject fluids into a
patient's circulatory system.
[0005] Most common reasons for venipuncture is to obtain blood for
diagnostic purposes, to monitor levels of blood components, and to
administer therapeutic treatments such as medications (e.g.,
intravenous antibiotics), nutrition, or chemotherapy for cancer
patients. Other reasons for venipuncture include removing blood due
to excess levels of iron (e.g., chelation therapy) or erythrocytes
(i.e., red blood cells) or to collect blood for later uses such as
donor blood and transfusions. All of these processes require access
to a vein via venipuncture.
[0006] During conventional venipuncture the user (e.g.,
phlebotomist, nurse, doctor or other medical personnel) positions
the needle to be inserted over the chosen vein at an angle so as to
make sure the needle does not puncture the vein and exit the vein
on the other side, thus not being in contact with the blood supply
within the vein. The user's goal is to position the needle tip
within the vein so that there is access to the blood within the
vein, whether for blood collection or for insertion of medication,
fluids or other compositions into the blood supply of the
individual or patient. However, this goal may be complicated as the
vein chosen for the venipuncture is typically supported by fatty
tissue in the cells that make up the connective tissue, and the
chosen vein may lie between the skin and the underlying muscle or
bone. So typically the user relies upon visual cues to locate the
vein and perform the venipuncture.
[0007] Further, the user may position a tourniquet at a location
such that the blood increases below the tourniquet and the vein
"throbs" making it easier to locate and puncture. The user may also
touch and feel the skin of the individual or patient and attempt to
locate the vein in this manner, together with a visual
observation.
[0008] Once the needle tip is inserted into the skin the user may
also use tactile senses by trying to "feel" where the needle tip is
in relation to the vein. Since the needle tip is inserted into the
skin layer, it passes through the fatty tissue layer and into the
wall of the vein which acts as a third layer. Depending on the
resistance felt by the user, the needle angle may be adjusted as
well in order to puncture the vein wall without passing through to
the other side of the vein and ensuring contact with the blood
within the vein. Once the needle tip is successfully within the
vein and in contact with the blood the needle angle may be adjusted
depending on the connection at the other end of the needle such as
a vacuum bottle for blood collection or an intravenous liquid for
insertion into the blood flow of the individual or patient.
[0009] In certain instances the individual patient may experience
anxiety or even pain depending on the needle tip diameter, the
structure of the individual's veins and whether his or her veins
have a tendency to collapse when punctured, and the experience
level of the user performing the venipuncture. If the venipuncture
is not successful there may be repeated attempts until successful
completion. Multiple attempts may add to the pain and the anxiety
of the individual or patient, especially for a pediatric patient,
elderly patient, a special needs individual, or a person with
anxiety issues.
[0010] One problem which may occur during the venipuncture is
movement of the vein targeted for puncture. As the vein is often
difficult to hold steady the vein itself being targeted for
puncture may roll or move sideways. Further, the needle tip itself
on insertion into the skin layer may in fact push the vein to the
side and out of the path of the needle tip itself. The patient may
also move the body part where the venipuncture is being performed.
Upon any of these problems the venipuncture is not successful and
further attempts must be made resulting in certain trauma to the
individual or patient's skin layer and layers below, as well as to
the individual's psyche and anxiety.
[0011] In certain circumstances the user may try to use his or her
own finger applying pressure to the patient's body part so as to
secure the vein from movement, but then the user is exposed for any
subsequent sudden movement by the patient and possible puncture of
the needle into the user's finger rather than puncturing the
vein.
[0012] Vein access is critically important especially in patients
who need continual access to their circulatory system, such as
patients receiving chemotherapy or dialysis. Renal failure is a
prevalent chronic disease in the United States with approximately
600,000 patients. The term renal failure refers to the inability of
the patient's kidneys to properly rid the patient's blood supply of
waste products such as creatinine, urea, and free water. The most
common treatment for this condition is hemodialysis. Hemodialysis
(or commonly referred to as dialysis) is the process of
extra-corporally removing the waste product from the blood supply
by circulating the patient's blood through a dialysis machine,
which "purifies" the blood of unwanted waste materials and returns
the blood to the patient.
[0013] There are various techniques in which dialysis is done, but
the more desirable and common technique is through what is known as
an AV fistula. For the purposes of dialysis, an AV (or Arterial
Venous) fistula is a surgical procedure to connect the vein and
artery. The AV fistula is accessed by inserting two needles, one
needle for drawing the blood to circulate through the dialysis
machine and a second needle to return to blood back into the
patient.
[0014] One common complication with this procedure occurs when the
vein is not fully dilated--the needle often does not puncture the
vein properly and causes blood to extravasate, causing the swelling
and hematoma formation. Worse, improperly puncturing the AV fistula
can actually damage the AV fistula making recannulation not
possible. Apart from the destruction of the fistula, the patient
suffers from pain and discomfort especially from the hematoma.
Ideally, the needle should enter the vein directly only piercing
the vein where it entered. By entering directly into the vein and
not puncturing the side or back walls of the vein, the needle can
access the AV fistula and allow the dialysis to commence with
minimal extravasation and the morbidities associated with it.
[0015] Thus, there exists a need for a guide to assist in the
proper insertion of a needle into a vein. While certain vein guides
have been the subject of patents and applications, they have
notable problems. For instance, they may be too binding and
constricting on the patient, especially an elderly, pediatric or
anxious patient. They may also be too large and wieldy to use
easily in a clinic or blood collection site such as Quest
Diagnostics, Inc. or Laboratory Corporation of America
(LabCorp).
[0016] A further need exists for a cheaper and easily available
guide which may be used by hospitals, clinics and even small
individual doctor's offices. A further need exists for a guide
which is flexible and not constricting on a patient while in use. A
further need exists for a guide which secures the needle once
inserted into the individual's body part.
[0017] These and other needs are met by the present invention
including a needle guide assembly apparatus for vein access and
method of use. Other advantages of the present invention will
become apparent from the following description and appended
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is one embodiment of a needle guide assembly for vein
access of the present invention.
[0019] FIG. 2 is one embodiment of a guide slide assembly of the
present invention.
[0020] FIG. 3 is an exploded view of one embodiment of the present
invention.
[0021] FIG. 4 is a further embodiment of the present invention.
[0022] FIG. 5 is an embodiment of the present invention and a
needle ready for use with the present invention.
[0023] FIG. 6 is an embodiment of the present invention in use on
an arm of a patient and showing a needle in use with the present
invention.
SUMMARY OF THE INVENTION
[0024] This invention provides an apparatus for guiding a needle
into a vein. The invention further provides an apparatus for
securing an inserted needle into a vein during venipuncture. The
invention further provides for a method of use including
venipuncture.
[0025] The invention includes a needle guide assembly for vein
access. The vein access needle guide assembly is the conduit
through which the needle is guided, inserted and may be secured
during venipuncture. A portion of the vein access needle guide
assembly may be transparent or translucent to allow the user
performing the venipuncture to properly align the needle with the
target vein in an individual or patient. In one embodiment, the
vein access needle guide assembly apparatus includes a retaining
means such as an adhesive backed plastic piece with an aperture
such as a hole, functioning as a guide, in the middle of the
plastic piece. In this embodiment the aperture may have a "track"
that when aligned properly above the targeted vein or even a
fistula, would guide the needle into the vein at the proper angle,
therefore reducing the risk of extravasation. The vein access
needle guide assembly may include additional portions joined on
each side of a guide slide assembly to secure the vein access
needle guide assembly to the patient's skin when in use, which have
an adhesive backing or other configuration to be affixed onto the
skin.
[0026] The method of use of the invention includes placing the
inventive vein access needle guide assembly onto the body part of
the individual or patient at the location of the target vein or
fistula, retaining the vein access needle guide assembly on the
skin such as by adhesion, inserting the needle into the groove and
aperture of the vein access needle guide assembly, puncturing the
vein while at the same time securing the needle in place within the
vein while extending out of the skin.
[0027] Other embodiments of the inventive apparatus and method are
disclosed below.
DETAILED DESCRIPTION OF THE INVENTION
[0028] Reference will now be made to the drawings wherein like
reference numerals may identify similar structural features or
aspects of the subject invention. For purposes of explanation and
illustration, and not limitation, a view of an exemplary embodiment
of the needle guide assembly for vein access is shown in FIG. 1 and
is designated generally by reference character 100. Other
embodiments of the vein access needle guide assembly and methods in
accordance with the invention, or aspects thereof, are provided in
FIGS. 2 through 6.
[0029] Referring now to FIGS. 1 through 6, a vein access needle
guide assembly 100 is shown to have a guide slide assembly 110
including a guide slide comprising a concave portion 120 and a
convex portion 130. The guide slide assembly 110 may be made out of
a rigid or semi-rigid material and could be translucent or
transparent. The guide slide assembly 110 has convex 130 and
concave 120 portions to accommodate and guide a needle as it is
inserted into the patient. Further, the convex portion 130 of the
guide slide assembly 110 may secure the needle as it will overlay
the needle when inserted into the patient's skin during the
venipuncture. In certain embodiments the convex and concave
portions may be reversed, or only one portion may be included,
either the convex portion alone or the concave portion alone.
[0030] The vein access needle guide assembly 100 further includes a
retaining means such as at least one adhesive side strap 140 which
secures the vein access needle guide assembly 100 to the skin of
the patient when in use. The adhesive side strap 140 may be
comprised of a polymer film, plastic, nonwoven or woven material,
or the material may be combinations thereof. This material is
preferably non-absorbent or essentially non-absorbent and
preferably flexible. The adhesive of the adhesive side strap 140
should be capable of maintaining the adhesive property when wet
given the possibility of blood or liquid medications being in
contact with the vein access needle guide assembly 100 when in use.
The adhesive may be contained on the adhesive side strap 140 itself
or the adhesive may be applied to both the adhesive side strap 140
and guide slide assembly 110 in the same step when producing the
vein access needle guide assembly 100. Such difference may be seen
in FIGS. 3 and 4 wherein the adhesive layer 150 is either a longer
strip layer below the adhesive side strap 140 and guide slide
assembly 110 while above the paper layer 160, as shown in FIG. 3.
In another embodiment the adhesive is broken into portions and
located only below the guide slide assembly 110, as the adhesive
side strap 140 is provided with a separate adhesive layer prior to
assembly of the vein access needle guide assembly 100. In certain
embodiments the adhesive layer 150 may have an opening or aperture
which corresponds with the aperture 125 of the guide slide assembly
110, or may be smaller or may be larger than the aperture 125, or
even have a multiple of openings, In one embodiment the opening or
aperture in the adhesive layer 150 is of a size such that the
convex portion opening is unencumbered (i.e., is afforded clear
access) through the adhesive layer 150 so as to permit entry of the
needle tip for reaching the skin. In yet another embodiment the
adhesive layer 150 may be a solid layer below the aperture 125. In
an alternate embodiment the adhesive layer 150 may be as shown in
FIG. 4.
[0031] The adhesive side strap 140 includes a layer of adhesive on
the bottom to adhere to the patient's skin when in use. The
adhesive may be acrylic, polymeric or any natural or synthetic
adhesive capable of adhering to a patient's skin when in use and
either re-adhering or capable of being removed from the patient's
skin with some force but not enough to remove the skin layer of the
patient. Any combinations of the adhesives named and those known in
the art may be used. IN general any retaining means may be employed
which is capable of retaining the needle guide assembly to the skin
of the patient while in use.
[0032] The vein access needle guide assembly 100 may be produced in
a plurality of sizes, with different sized guide slide assemblies
110 to accommodate the different standard needle gauges used by
medical professionals. One example is a rectangular vein access
needle guide assembly with dimensions of about 5 mm to about 50 mm
wide and about 10 mm to about 100 mm long with the concave portion
120 and convex portion 130 forming an aperture 125 with a diameter
of about 0.5 mm to about 10 mm. These dimensions may be changed
depending on the patient's size and the size of the needle. For
example, the size may be changed dependent on the target patient,
such as children compared to adults. In one example the dimensions
are about 10 mm to about 30 mm wide and about 45 mm to about 75 mm
long with the concave portion 120 and convex portion 130 forming an
aperture 125 with a diameter of about 1.0 mm to about 3.5 mm.
[0033] The angle of the guide slide 110 is to be configured to
appropriately guide the needle into the vein without causing
extravasation. Those appropriately trained in the art will
appreciate that if a needle is inserted at the wrong angle or too
far within a vein that it will damage the vein wall, causing
discomfort, bruising, and even hematoma.
[0034] FIG. 2 shows the guide slide assembly 110 in more detail.
The guide slide assembly 110 has a concave portion 120 and convex
portion 130 forming an aperture 125. The aperture 125 may be
defined only by the edges of each of the concave portion 120 and
convex portion 130 or it may be larger when viewed from a top view.
The guide slide assembly 110 may optionally include one or more
guide notches 170. In a further embodiment shown in FIG. 5 the
guide slide assembly 110 may include a directional indicator 175,
which may be a graphic, such as an arrow pointing in the direction
for the user to insert the needle into the vein access guide slide
assembly 100. The direction indicator 175 could be comprised of
words such as "INSERT HERE" or "UP" or any combination of graphics
and/or words.
[0035] In an alternate embodiment of the guide slide assembly 110
only a concave portion 120 is included to guide the needle into the
patient's skin when in use. In this embodiment the remaining
portion of the guide slide assembly 110 is flat and flush with the
surface of the patient's skin. Again, an optional graphic may be
included. In yet another embodiment of the guide slide assembly 110
has a concave portion 120 which is formed to extend beneath the
underside of the guide slide assembly 110. In a further embodiment
the concave portion 130 may be formed as a depression in the guide
slide assembly 110. Other combinations are possible.
[0036] Reference character 110 of FIGS. 3 and 4 is a vein access
needle guide assembly with adhesive-backed side straps 140 shown;
such an assembly would further allow the vein access needle guide
assembly 100 to affix securely atop the patient's skin without
slipping off. FIG. 3 shows one embodiment of the vein access needle
guide assembly 100 with the guide slide assembly 110 in a position
on top of the adhesive-backed side straps 140 while FIG. 4 is a
different embodiment of the vein access needle guide assembly 100
wherein the guide slide assembly 110 is in a position with the
edges of one distal end affixed below a distal end of the
adhesive-backed side straps 140.
[0037] FIG. 3 is an exploded view of one embodiment of the vein
access needle guide assembly 100 with the different parts shown.
The vein accessible needle guide assembly 100 with two side straps
140 to be affixed on each side of a distal end of the guide slide
assembly 110 is shown with an adhesive layer 150 as well as a paper
liner layer 160 that protects the adhesive portion until use. It
may be preferable that the paper liner layer 160 have off-set peel
tabs (not shown).
[0038] FIG. 5 shows a needle 190 entering into the vein access
needle guide with side straps 110 that are affixed atop of a
patient's skin. It can be noted that the needle slide 110 is
aligned atop of the vein so that when a needle is inserted it will
enter the cannula of the vein.
[0039] A needle 180 is also shown in FIG. 5 where the needle tip
1090 is on the edge of the concave portion 120 of the guide slide
assembly 110 but not within the aperture 125. The needle 180 may be
any conventional needle having a needle tip 190 of various
diameters capable of insertion into the aperture 125. The needle
shown in FIGS. 5 and 6 is one example of a needle 180 and in this
embodiment is a winged-tip butterfly needle including a winged
stabilizer 185. Some examples of needle tip 190 diameters are about
1.8 mm to about 2.2 mm These dimensions may change depending on the
size of the needle. In use, the needle 180 is moved in a direction
to correspond to the flow of blood in the target vein, and in this
instance is moved such that the needle tip 190 is aligned with the
concave portion 120 of the guide slide assembly 110 and moves into
the aperture 125 and is inserted into the patient's skin, with the
convex portion 130 and the entire guide slide assembly 110 and the
vein access needle guide assembly 100 securing the needle 180 while
in use.
[0040] It is envisioned that the vein access needle guide assembly
100 would be packaged in a sterilized package, either as a
stand-alone product or in combination with multiple needle guides
or other products such as a needle. Other kits including the vein
access needle guide assembly 100 could include a cleansing agent in
a sterile package, a tourniquet, the vein access needle guide
assembly 100, a needle, a piece of sterile gauze and a sterile
bandage.
[0041] A method of venipuncture using the inventive vein access
guide assembly 100 may include a number of steps. First, the target
vein is chosen (if an AV fistula is not the target location) such
as on the outside of the forearm, on the back of the hand, in the
antecubital fossa or any other body location. Next, the skin on the
patient located where the user wants to access the vein is cleaned
by a cleansing agent. The cleansing agent used to prepare the
insertion site may be iodine, povidone-iodine, or ethyl alcohol.
The cleansing agent may be an alcohol swab, preferably 70%
isopropyl alcohol. The vein is palpated, and to dilate the vein a
tourniquet may be wrapped around the arm proximal to the intended
site of puncture. Optionally a tourniquet may be placed at a
location near the target vein so that the target vein protrudes or
is more easily visualized or subject to tactile manipulation and
touch. The patient may be asked to pump his or her fist if the
target vein is located in the arm.
[0042] Next, if the vein access needle guide 100 is packaged in a
sterile packaging, then packaging is opened. The vein access guide
assembly 100 is aligned with the target vein such that the concave
portion 120 is aligned with the flow of the blood in the target
vein as the inserted needle would also align with the blood flow.
The paper liner layer 160 is peeled back exposing the adhesive
layer 150 and the vein access needle guide 100 is affixed atop the
patient's skin, appropriately aligning over the target vein,
preferably with the needle guide slide 120 located over the target
vein. As shown in FIG. 6, a needle 180 is inserted into the guide
slide 110 to access the vein and the concave portion 120 secures
the needle 180. The angle of the needle tip 190 may be between
about 5.degree. to about 90.degree., preferably about 10.degree. to
about 40.degree., and more preferably about 15.degree. to about
30.degree., dependent on the diameter of the needle tip and the
size of the target vein 200. After the skin is punctured, little
resistance should be felt by the user as the needle tip 190 should
pass through the subcutaneous tissue, but a sudden slight
resistance may be felt as the needle tip 190 hits the wall of the
vein. At this point the needle tip 190 may be cautiously advanced,
with the needle 180 held nearly flush with the skin as the needle
180 is in the concave portion 120 of the guide slide assembly 110
and secured by the convex portion 130. Slight upward pressure
applied by the user and the guide slide assembly 110 itself may aid
in keeping the needle tip 190 in the target vein 200 as the needle
tip 190 is advanced into the lumen of the target vein 200. A
successful venipuncture results in blood flowing back into the hub
of the needle 180 or into the catheter or vacuum tube (neither
shown) attached to the distal end of the needle 180, and the needle
tip 190 usually can be felt to be in the vein. If these signs are
absent, the needle tip 190 is not in the target vein 200, in which
case it is usually best to remove the needle 180, apply pressure to
the puncture site, and start the procedure again, using new
equipment.
[0043] In a successful venipuncture using the inventive vein access
needle guide assembly 100, the user now has access to the patient's
vein and blood may be drawn and fluids or medication put into the
circulatory system. At a later time the needle 180 is removed from
the patient's vein by the user, the vein access needle guide
assembly 100 is removed, and optionally a sterile piece of gauze,
and a conventional adhesive bandage is placed atop the location on
the patient's skin where the vein was accessed to provide pressure
until the local bleeding stops.
[0044] The inventive method may be used to obtain blood for
diagnostic purposes, to monitor levels of blood components, to
administer therapeutic treatments such as medications (e.g.,
intravenous antibiotics), nutrition, or chemotherapy for cancer
patients. Other uses of the inventive venipuncture method and other
uses for inventive vein access needle guide assembly 100 include
removing blood due to excess levels of iron (e.g., chelation
therapy) or erythrocytes (i.e., red blood cells) or to collect
blood for later uses such as donor blood and transfusions. Other
uses may be contemplated if relating to insertion of a needle into
a patient's skin to access a vein.
[0045] The inventive vein access needle guide assembly 100 assists
the user in the proper insertion of a needle into a vein. The
inventive vein access needle guide assembly 100 is portable and
does not impinge on the patient's skin but rather is easily placed
on the patient's skin in the location of the target vein and is
retained on the skin sufficiently for the venipuncture and securing
of the needle without being so secure that the user cannot remove
the vein access needle guide assembly 100 easily with minimal
force. The vein access needle guide assembly 100 of the present
invention may lessen anxiety and pain for the patient in that that
vein access needle guide assembly 100 is small and pliable while
also assisting in the venipuncture which results in a quicker
venipuncture process, as well as a more accurate process. Further,
the user may experience less anxiety also based on the needle guide
slide 110 of the inventive vein access needle guide assembly 100
and being able to easily access the target vein and not having to
rely on the users own visual cues or tactile impressions such that
the risk of puncture of the user's finger is lessened or even
totally removed.
[0046] Further, the inventive method and inventive vein access
needle guide assembly 100 may be used in venipuncture related to a
fistula, including an AV fistula. The patient may therefore
experience less pain and the user experience a quicker and/or
easier and/or more accurate and less stressful, venipuncture of the
skin surrounding the AV fistula.
[0047] The inventive method and inventive vein access needle guide
assembly 100 may be cheaper and more easily available than current
vein guide apparatuses and thus may be used by hospitals, clinics
and even small individual doctor's offices.
[0048] The invention has been described in terms of embodiments
thereof, but is more broadly applicable as will be understood by
those skilled in the art. The scope of the invention is only
limited by the following claims.
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